Regulations/Legal

Editor's Note The Centers for Medicare & Medicaid Services should measure surgeon spending at a group level or incorporate multiple years of data to reduce misclassification of surgeon performance in its Merit-based Incentive Payment System (MIPS) program, this study finds. University of Michigan researchers found that annual cost-profiles of individual…

Editor's Note The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years. Under the existing pathway, manufacturers can pursue expedited approval for devices that are…

Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…

AORN’s updated Guideline for Sterilization is based on a recent review of evidence in peer-reviewed journals and regulations from 2012 to 2017. In addition to guidance for sterilizing reusable medical devices to be used in perioperative and procedural settings, the updated guideline points to findings that substantiate current practices, and…

Editor's Note New data from the Centers for Medicare & Medicaid Services (CMS) shows that 93% of eligible clinicians who participated in the Merit-Based Incentive Payment System (MIPS) under the Quality Payment Program (QPP) received positive payment adjustments for their performance last year, the November 9 EHR Intelligence reports. Only…

Editor's Note Cigarette smoking rates in the US have dropped to the lowest level ever recorded, according to the November 9 Morbidity and Mortality Weekly Report. The smoking rate for adult smokers fell from 15.5% in 2016 to 14% in 2017, a rate 67% lower than it was in 1965.…

Editor's Note The Joint Commission on November 7 announced a new requirement of participation in a national joint replacement registry for its advanced Total Hip and Total Knee Replacement (THKR) certification, effective July 1, 2019. The Disease Specific Care Performance Measurement (DSPM) standard DSPM.4, element of performance (EP) 2 will…

Editor's Note Healthcare accreditation organization DNV GL Healthcare on November 7 launched the first sterile processing program certification in the US. The program recognizes excellence in an organization’s sterile processing department within the scope of infection prevention and control, surgical services, endoscopic services, and related departments. An important part of…